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216 device results listed.

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06973262861082

Sample Diluent

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861082
Basic UDI-DI: 69732628600020ZC
Reference: 6012303
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262861068

Substrate

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861068
Basic UDI-DI: 69732628600019ZT
Reference: 01.09.40.10.01.07
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262861044

Substrate

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861044
Basic UDI-DI: 69732628600018ZR
Reference: 6012201
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262860801

Z5 LD

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262860801
Basic UDI-DI: 69732628600013ZF
Reference: 01.09.31.05.Z5.08
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262860795

Z5 LB

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262860795
Basic UDI-DI: 69732628600012ZD
Reference: 01.09.31.05.Z5.07
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262860788

Probe Cleanser

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262860788
Basic UDI-DI: 69732628600010Z9
Reference: 01.09.51.01.Z.02
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262860139

Nucleic Acid Extraction Kit (Magnetic Bead Method)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262860139
Basic UDI-DI: 69732628600015ZK
Reference: 01.09.20.00.T1.07
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06941967242284

EXC460, EXC470

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242284
Basic UDI-DI: 6973262860014626
Reference: 0112804
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967237839

Ab Matrix Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967237839
Basic UDI-DI: 6973262860011923
Reference: 052304001
EMDN: W0104080113
EMDN description: OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Zybio

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236757
Basic UDI-DI: 69732628600120ZH
Reference: Sample Probe Cleaning Solution
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967235910

Cell-free DNA Extraction Kit (Magnetic Bead Method)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967235910
Basic UDI-DI: 69732628600111ZG
Reference: 0301806
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967227038

C-Reactive Protein Kit (Immunoturbidimetric Method)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967227038
Basic UDI-DI: 69732628630110*********XH
Reference: 3011001
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967225089

Probe Detergent

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967225089
Basic UDI-DI: 697326286000692D
Reference: 042304005
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967225072

Concentrated Detergent

IVD Class AIVDR 2017/746Not intended for EU marketProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967225072
Basic UDI-DI: 69732628600070ZT
Reference: 042304002
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224600

H56 LD-II

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224600
Basic UDI-DI: 697326286000592A
Reference: 01.09.31.03.03.02
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224594

H56 LD-I

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224594
Basic UDI-DI: 6973262860005828
Reference: 01.09.31.03.02.02
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224556

Check-P

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224556
Basic UDI-DI: 6973262860006525
Reference: 01.09.31.01.Q.32
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224532

Cal-P

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224532
Basic UDI-DI: 6973262860006423
Reference: 01.09.31.00.01.03
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224501

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224501
Basic UDI-DI: 69732628600060ZQ
Reference: 01.09.31.03.01.03
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224471

SR-I

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224471
Basic UDI-DI: 69732628600063ZW
Reference: 01.09.30.01.01.04
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details